Fact Checking Claims that the Pfizer Vaccine Is Not Yet Approved

The FDA granted full approval in August.

A widely shared article from Red Voice America, which describes itself as being owned by “patriots” and fighting “false narratives against conservatives,” claims that “Biden BUSTED As Pfizer ADMITS There’s No Vaccine Approved By FDA In The U.S. In Recorded Call.” The article claims to have a phone call recording of a Pfizer employee who allegedly “admits” that the Pfizer vaccine has not been approved by the FDA.

In an email to The Dispatch Fact Check, a spokesperson for Pfizer confirmed that the Pfizer COVID-19, which has been available for use under an Emergency Use Authorization (EUA) since December 11, 2020, has been granted FDA approval. The approval was noted at the time by many major media outlets, including the Washington Post, NPR, the New York Times, CNN, and the Associated Press, among others.

On August 23, the FDA released a press release announcing FDA approval of the Pfizer-BioNTech COVID-19 vaccine: “Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older.”

Pfizer also announced FDA approval of the Pfizer-BioNTech COVID-19 vaccine on August 23: “Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration (FDA) approved the Biologics License Application (BLA) for COMIRNATY® (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 16 years of age and older. COMIRNATY is the first COVID-19 vaccine to be granted approval by the FDA.”

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